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J
ANE
W
EITZEL
15 Park Royal Bay
Winnipeg, MB R3P 1P2
Home:
204.488.2168
mljweitzel@msn.comCell: 204.298.3014
SUMMARY OF QUALIFICATIONS
Over 35 years experience in analytical chemistry in highly regulated, fast paced companies with the last 5 years
at the director/associate director level. Expertise includes managing labs compliant with ISO/IEC 17025, cGMP,
and ALACC; use of measurement uncertainty; and improving lab system efficiency. Analytical decision maker
with excellent people skills. Internationally recognized expert in laboratory management systems and lab
accreditation.
Appointed to USP Expert Committee on Statistics for 2015 to 2020 cycle
Appointed to USP Expert Committee on Reference Standards for 2010 to 2015 cycle.
Appointed to Chinese NIFDC Reference Standards Committee 2013 - 2016
Member of USP Expert Panel on Method Validation and Verification.
Past Chair of “Analytical Laboratory Accreditation Criteria Committee” of AOAC International. This
committee publishes “
AOAC INTERNATIONAL Guidelines for Laboratories Performing Microbiological and
Chemical Analyses of Food and Pharmaceuticals
”, the criteria that are used to assess laboratories for ISO
17025 accreditation.
Lead Auditor for Standards Council of Canada and A2LA for accreditation to ISO 17025 and ISO 17043.
Member of AOAC Statistics Committee.
PROFESSIONAL EXPERIENCE
Trainer and Consultant
Provided training and presentations to both the United States Pharmacopiea (USP) and FDA on many aspects of
Quality systems, specifically the use of Measurement Uncertainty to demonstrate compliance with specifications.
This resulted in my being invited by the FDA to speak about the use of Measurement Uncertainty at the FDA’s
Second International Analytical Methods conference in February 2011.
Wrote and maintained International Standards for lab accreditation.
Created and revised several international standards for accrediting laboratories. As a result labs around the
world are using these standards in many industries.
Assisted in creating the Standards Council of Canada PALACN 1579 guide
“Requirements for the
Accreditation of Mineral Analysis Testing Laboratories”
. This guide has been used for over 15 years now
to accredit labs in countries such as Russia, Peru, Mexico, US, and Canada.
Responsible for Quality Systems to support lab operations and manufacturing operations.
Experienced in implementing, maintaining, and improving compliance with cGMP regulations of many
regulatory bodies including US FDA, Health Canada, UK MHRA and others in drug and biologics
manufacturing facilities.
Managed and mentored people effectively, enabling them to work at their potential and to develop self-
directed teams, resulting in efficient work structures.
Learned new technologies quickly and worked with R & D scientists in order to apply Quality Systems in
a wide variety of technical and scientific businesses such as transdermal manufacturing, solid dosage
manufacturing, plasma collection, plasma fractionation, contract manufacturing, and the mining and
environmental industries.
Changed Quality Systems in response to regulatory actions such as Warning Letters and Consent Decrees.
Led a project in response to an FDA
consent decree to validate over 200 methods to today’s standards while maintaining normal lab
operations and ensuring compliance with regulatory requirements. This resulted in all methods being
validated to current standards, meeting a key requirement of the consent Decree.
AOAC OMB Meeting Book
108